Clinical Performance of Abbott RealTime Hepatitis C Virus (HCV) Genotype II Test

NCT00979979 | Completed

• 1 other identifier: 200906047D
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 4

Brief Summary

Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. Combination of peginterferon plus ribavirin therapy has become the current standard of care for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR) rate of 54-63% and more favorable response rates in patients with genotype 2/3 infection than those with genotype 1/4 infection. Therefore, accurate pre-treatment HCV genotype evaluation is of paramount importance to facilitate individualized therapy in the era of response guide therapy and specific-targeted antiviral therapy for HCV (STAT-C). Currently, direct HCV genetic sequencing for both the 5' untranslated terminal region (5'UTR) and non-structural 5B (NS5B) regions with subsequent phylogenetic tree analysis is considered the gold standard for determining HCV genotype and subtype. However, it is time-consuming and need special laboratory settings. Several commercial available reverse hybridization with type-specific probing assay (Inno-LiPA II) or simplified direct sequencing of the 5'UTR region were used to replace the two region sequencing method (Trugene HCV 5' NC genotyping kit). Nonetheless, data on the overall diagnostic accuracy varied. The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for determining the genotype(s) of HCV in plasma and serum from HCV-infected individuals. Based on genetic similarity, HCV has been classified into six major genotypes (1-6) and numerous subtypes. HCV genotype is predictive of the response of HCV-infected patients to peginterferon plus ribavirin combination therapy. The Abbott RealTime HCV Genotype II assay uses the Abbott m2000sp instrument for processing samples and the Abbott m2000rt instrument for amplification and detection. Furthermore, the Abbott m2000sp provides automated sample transfer and reaction assembly of the assay reagents in the Abbott 96-Well Optical Reaction Plate. The investigators aimed to evaluate the overall diagnostic accuracy of the currently available commercial HCV genotype kits (Abbott RealTime HCV Genotype II) by using 5'UTR and NS5A gene amplification and direct sequencing as the gold standard.

Conditions

Hepatitis C

Keywords

Hepatitis C; Genotype; Realtime PCR

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy for HCV genotype testing

  7 days

Study Arms (2)

HCV patients

HCV patients with detectable viremia; all sera are tested both by Abbott RealTime HCV genotype II test and by direct HCV sequencing both at 5'UTR and NS5B

Non-HCV patients

Patient without evidence of HCV infection (negative both for anti-HCV and HCV RNA); all sera are both tested by Abbott RealTime HCV genotype II test and by direct HCV sequencing at 5'UTR and NS5B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

255 HCV patients both positive for anti-HCV and HCV RNA and 18 patients without ant-HCV and HCV RNA; all 255 patients were tested for Abbott RealTime genotype II test and direct HCV sequencing at 5'UTR and NS5B for the sensitivity, specificity, and the overall diagnostic accuracy.

You may qualify if:

• HCV patients with both positive for anti-HCV and HCV RNA (Cobas Taqman, Roche Diagnostics, LOQ:25 IU/mL and LOD:10 IU/mL)
• Patients with signed informed consent

You may not qualify if:

• Patients without signed informed consent
• HCV patients without detectable HCV RNA (Cobas Taqman, Roche Diagnostics)

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Abbott Diagnostics Division: collaborator
• National Science and Technology Council, Taiwan: collaborator
• Department of Health, Executive Yuan, R.O.C. (Taiwan): collaborator

Study Sites (4)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Municipal Hospital, Ren-Ai Branch

Taipei, Taiwan

Location

Related Publications (1)

• Liu CH, Liang CC, Liu CJ, Lin CL, Su TH, Yang HC, Chen PJ, Chen DS, Kao JH. Comparison of Abbott RealTime HCV Genotype II with Versant line probe assay 2.0 for hepatitis C virus genotyping. J Clin Microbiol. 2015 May;53(5):1754-7. doi: 10.1128/JCM.03548-14. Epub 2015 Mar 4.

  PMID: 25740780 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient stored serum with detectable HCV RNA levels

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Chen-Hua Liu, MD

  National Taiwan University Hospital

  STUDY CHAIR

• Jia-Horng Kao, MD, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

• Chun-Jen Liu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Cheng-Chao Liang, MD, BS

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Chih-Lin Lin, MD, BS

  Taipei Municipal Hospital, Ren-Ai Branch

  PRINCIPAL INVESTIGATOR

• Chen-Hua Liu, MD

  National Taiwan University Hospital, Yun-Lin Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 18, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

TW (4)